Briglau 2 mg/ml, oogdruppels, oplossing

DO NOT use [Invented name]

• if you are allergic to brimonidine tartrate or any of the other ingredients of this medicine (listed in section 6).
• if you are taking monoamine oxidase (MAO) inhibitors or certain antidepressants, for example tricyclic antidepressants or mianserin. If you are already taking an antidepressant drug, ask your doctor if you can use [Invented name].
• if you are breast-feeding.
• in infants/babies (from birth until 2 years).

Warnings and precautions

Consult your doctor before using this medicine if you:

• suffer or have suffered from depression, reduced mental capacity, reduced blood supply to the brain, heart problems, a disturbed blood supply of the limbs or a blood pressure disorder.
• have or have had in the past kidney or liver problems.

Children and adolescents

[Invented name] is not recommended for use in children under 12 years of age. If [Invented name] is prescribed for a child under 12 years, please speak with your doctor before using.

Other medicines and [Invented name]

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Tell your doctor if you are taking any of the following medicines as they could affect your treatment with [Invented name]:

• pain killers, sedatives, opiates, barbiturates or are regularly consuming alcohol.
• anaesthetics.
• medicines to treat a heart condition or to lower blood pressure.
• medicines that can affect the metabolism like chlorpromazine, methylphenidate and reserpine.
• medicines which work on the same receptor as [Invented name], for example isoprenaline and prazosin
• monoamine oxidase inhibitors and other antidepressants.
• medicines for any condition, even if unrelated to your eye condition.

Also, tell your doctor if the dose of any of your current medicines is changed.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. Tell your doctor if you are pregnant or planning to become pregnant.

[Invented name] should not be used while breast-feeding.

Driving and using machines

Brimonidine tartrate may cause blurred or abnormal vision which may seem worse at night or in reduced lighting.

Brimonidine tartrate may also cause drowsiness or tiredness in some patients.

If you experience any of these symptoms, do not drive or use machinery until the symptoms are cleared.

[Invented name] contains benzalkonium chloride

Benzalkonium chloride – a preservative in [Invented name] - may cause eye irritation and is also known to discolour soft contact lenses. Therefore, avoid contact with soft contact lenses. If you wear soft contact lenses, take them out before using [Invented name] and then wait 15 minutes after using the drops before inserting your lenses.

Always use [Invented name] exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Adults, adolescents and children over 12 years

The usual dose is one drop twice a day in the affected eye(s), approximately 12 hours apart.

Children under 12 years

[Invented name] must not be used for infants below 2 years of age. [Invented name] is not recommended for use in children (from 2 to 12 years).

Instructions for use

[Invented name] is for use as eye drops only. Do not swallow.

Always wash your hands before applying eye drops. Your prescription label tells you how many drops to use at each dose. If you use [Invented name] with another eye drop, wait 5-15 minutes before applying the other eye drop product.

Apply your eye drops in the following way:

1. Tilt your head back and look at the ceiling.
2. Gently pull the lower eyelid down until there is a small pocket.
3. Squeeze the upturned dropper bottle to release a drop into your eye.
4. Whilst keeping the affected eye closed, press your finger against the corner of the closed eye (the side where the eye meets the nose) and hold for 1 minute.

Avoid touching the dropper tip against your eye or anything else. Replace and tighten the cap straight after use. If you wear soft contact lenses, take them out before using these eye drops and then wait 15 minutes after applying the drops before inserting your lenses. The preservative in these eye drops is known to discolour soft contact lenses.

If you use more [Invented name] than you should Adults

If you have placed too many drops of [Invented name] in your eye(s), it is unlikely to cause you any harm. Use your next dose at the normal time.

Children

Several cases of overdose have been reported in children receiving brimonidine tartrate containing eye drops as part of medical treatment of glaucoma. Signs include sleepiness, floppiness, low body temperature and breathing difficulties. Should this happen, contact your doctor immediately.

Adults and Children

If anyone accidentally swallows this medicine, contact your doctor immediately.

If you forget to use [Invented name]

If you forget a dose, apply it as soon as you remember. If, however, it is almost time for your next dose, you should skip the missed dose altogether and then follow your normal routine.

If you stop using [Invented name]

To be effective, these drops must be used every day. Do not stop using [Invented name] until your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, [Invented name] can cause side effects, although not everybody gets them.

The chance of having a side effect is described by the following categories:

Very common	Occurs in more than 1 in 10 patients
Common	Occurs in less than 1 in 10, but more than 1 in 100 patients
Uncommon	Occurs in less than 1 in 100, but more than 1 in 1,000 patients
Rare	Occurs in less than 1 in 1,000, but more than 1 in 10,000 patients
Very rare	Occurs in less than 1 in 10,000 patients, including isolated reports
	3

The following eye side effects may be seen with [Invented name]:

Very common:	Irritation of the eye (eye redness, burning, stinging, a feeling of something in the eye,
	itching, follicles or white spots on the see-through layer which covers the surface of the
	eye), blurred vision, an allergic reaction in the eye.
Common:	Local irritation (inflammation and swelling of the eyelid, swelling of the see-through
	layer which covers the surface of the eye, sticky eyes, pain and tearing), sensitivity to
	light, erosion on the surface of the eye and staining, eye dryness, whitening of the see-
	through layer which covers the surface of the eye, abnormal vision, inflammation of the
	see-through layer which covers the surface of the eye.
Very rare:	Inflammation within the eye, reduction in pupil size
Side effects where the occurrence is unknown:	Itching of eyelids

You may also experience the following effects in other parts of the body:

Very common:	Headache, dry mouth and tiredness/drowsiness.
Common:	Dizziness, cold-like symptoms, problems with your stomach and/or bowel, abnormal
	taste or general weakness.
Uncommon:	Depression, palpitations or changes in heart rate, dry nose and general allergic reactions.
Rare:	Shortness of breath.
Very rare:	Sleeplessness, fainting and high or low blood pressure.
Side effects where the occurrence is unknown:	Skin reactions including redness, face swelling,
		itching, rash and widening of blood vessels

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

This medicinal product does not require any special storage conditions.

Keep this medicine out of the sight and reach of children.

Do not use the bottle if the tamper-proof seal on the bottle is broken before first use.

Do not use this medicine after the expiry date which is stated on the bottle label and the carton after EXP. The expiry date refers to the last day of that month.

Throw the bottle away 28 days after opening, even if there is solution remaining.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What [Invented name] contains

• The active substance is brimonidine tartrate. One ml solution contains 2.0 mg brimonidine tartrate, equivalent to 1.3 mg of brimonidine.

• The other ingredients are benzalkonium chloride (as a preservative), poly(vinyl alcohol), sodium chloride, sodium citrate, citric acid monohydrate, sodium hydroxide or hydrochloric acid (for pH- adjustment) and water for injection. See end of Section 2 for further important information on benzalkonium chloride.

What [Invented name] looks like and contents of the pack

[Invented name] is a clear, slightly yellowish eye drop solution in a plastic bottle. Each bottle contains 5 ml eye drops.

[Invented name] is available in pack of 1 bottle.

In het register ingeschreven onder RVG: 110407

Briglau 2 mg/ml, oogdruppels, oplossing

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Medana Pharma SA

10 Władysława Łokietka Str., 98-200 Sieradz

Poland

Manufacturer

Pharmaceutical Works POLPHARMA SA

19 Pelplińska Str., 83-200 Starogard Gdański

Poland

This leaflet was last revised in {MM/YYYY}